Investigate the safety of single vaccination and simultaneous vaccination with multiple vaccines (PCV7, Hib, DTP etc.).

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

Side effects occur within 14 days after vaccination (general reaction and local reaction)

Key secondary outcomes

Other adverse events

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

0

months-old

<=

Age-upper limit

60

months-old

>

Gender

Male and Female

Key inclusion criteria

1]Age: over 2 month and under 5 years of age
2]Subjects whose parents require single vaccination or simultaneous vaccination,
3]Each vaccine are determined to be appropriate on pre examination by physicians

Key exclusion criteria

1]Age: under 2 and over 5 years of age
2]Subjects whose parents do not require vaccination to their children
3]Vaccination is determined to be inappropriate on pre examination by physicians

Bacterial meningitis is one of the most serious infectious diseases in children. It is seen as a thread because of leaving after effects and having an influence on life prognosis with a difficulty of early diagnosis. It is reported that in US and Europe, the vaccine for Haemophilus influenza type B (HIB), main pathogen of bacterial meningitis, was introduced and 7-valent pneumococcal conjugate vaccine (PCV7) became the regular vaccine schedule that significantly reduced bacterial meningitis. In Japan that the effective provision to preventable bacterial meningitis by vaccination is to give PCV7 and Hib concomitantly, which were released in 2010 and 2008. Although in other countries, simultaneous vaccination that gives multiple vaccines at one visit is common, in Japan, single vaccination is basically permitted except for cases physicians admit simultaneous vaccination. In order to having necessary vaccine effectively without frequent visits to physicians, simultaneous vaccination, PCV7 and Hib whose timing of vaccination are nearly the same, and DTP of regular vaccination schedule, is likely to increase. In the meantime, there are some physicians and parents concerning about an increasing possibility of side effects caused by simultaneous vaccination. Therefore, at this time, we are planning on investigating the safety of single vaccination and simultaneous vaccination. This research would give expectations for the safety of simultaneous vaccination to infants in Japan and will be expected to increase selection of vaccination methods that results in availability of efficient vaccination to children, their parents, and medical experts without frequent visits to a clinic.